FDA.reportPublic FDA data

Methocarbamol

Product NDC
43063-903
11-digit product format
430630903
Labeler code
43063
Product ID
43063-903_32d385d8-7606-fee1-e063-6394a90a7a59
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methocarbamol Tablets
Dosage form
TABLET, COATED
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA209312
Marketing category
ANDA
Marketing start
2018-07-02
Substance
METHOCARBAMOL
Active strength
500 mg/1
Pharmacologic classes
Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Methocarbamol
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHOCARBAMOL500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii125OD7737X
Rxcui197943

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
492965be-47bc-38cf-57c4-5c5e0343abe5Product name620211028
02a01e9c-3f4e-c0ee-6542-be865127aea3Product name820190205

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43063-903-18Methocarbamol18 in 1 BOTTLE, PLASTICTABLET, COATED1818
43063-903-20Methocarbamol20 in 1 BOTTLE, PLASTICTABLET, COATED2018
43063-903-24Methocarbamol24 in 1 BOTTLE, PLASTICTABLET, COATED2418
43063-903-28Methocarbamol28 in 1 BOTTLE, PLASTICTABLET, COATED2818
43063-903-30Methocarbamol30 in 1 BOTTLE, PLASTICTABLET, COATED3018

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43063-903-18EA - Each43063-9037f4c0d64-7a7d-4621-8d1b-b529a0e867f412022-06-06
43063-903-20EA - Each43063-9035c947c7a-0706-4086-8e6e-cee27fba719312019-01-24
43063-903-24EA - Each43063-903ec043824-4b64-474c-8173-cc2d0d8f4c4512019-04-11
43063-903-28EA - Each43063-90360381c4e-41bc-401f-970f-92c64c9a2d2d12019-01-24
43063-903-30EA - Each43063-9039ed3ac25-4217-4793-8943-3d471929d10712019-01-24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-903METHOCARBAMOL (METHOCARBAMOL TABLETS) TABLET, COATED [PD-RX PHARMACEUTICALS, INC.]18Current NDC, Legacy NDC, 5 package rows20250417_7dafab15-db4c-4425-b1a2-e56433ecccf6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197943methocarbamol 500 MG Oral TabletPSN7dafab15-db4c-4425-b1a2-e56433ecccf618
197943methocarbamol 500 MG Oral TabletSCD7dafab15-db4c-4425-b1a2-e56433ecccf618

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43063-903-184306309031818 TABLET, COATED in 1 BOTTLE, PLASTIC (43063-903-18) 2022-05-020000-00-00NoNoCurrent
43063-903-204306309032020 TABLET, COATED in 1 BOTTLE, PLASTIC (43063-903-20) 2018-11-080000-00-00NoNoCurrent
43063-903-244306309032424 TABLET, COATED in 1 BOTTLE, PLASTIC (43063-903-24) 2019-02-250000-00-00NoNoCurrent
43063-903-284306309032828 TABLET, COATED in 1 BOTTLE, PLASTIC (43063-903-28) 2018-11-080000-00-00NoNoCurrent
43063-903-304306309033030 TABLET, COATED in 1 BOTTLE, PLASTIC (43063-903-30) 2018-11-140000-00-00NoNoCurrent